Federation of Pharma Entrepreneurs (FOPE) has welcomed the government’s move to categorise over the counter (OTC) drugs, saying such move will widen the scope of drugs which can be covered under License in Form 20A thereby increasing accessibility of consumers to drugs and reducing rules’ violation.

As of now prescription is required for drugs required for treating even minor ailments which are safe to be dispensed without prescription. It is a welcome move by the government in forming a committee to look into categorization of OTC drugs which is in line with Prime Minister Narendra Modi’s vision of improving accessibility and affordability of drugs in the country. The initiative will also boost  “Ease of Doing Business”, said the FOPE president BR Sikri.

The Form 20A contains decongestants (for cough and cold), anti-inflammatory drugs, antacids, external preparations for skin and hormonal contraceptives, anti-allergies, antipyretic (for fever), antiemetic (for vomiting and nausea), muscle relaxants etc. Once categorization of OTC drugs is done, pharmacists will be able to dispense these drugs without a doctor’s prescription.

Said Sikri, “India is a vast country with various segments of people.  Almost 65 per cent people are not able to afford the cost of treatment. The government has very nominal budget on health when it is compared it with other countries. Doctor fee is one category of expenses which pains the patients. There are some categories of ailments like skin and hormonal problems, congestion problem, inflammatory problem, etc. Once schedule of OTC drugs comes out, patients will  have no botheration visiting doctors for treating such ailments. A qualified pharmacist can prescribe such medicines to the patients as dispensing of OTC drugs in pharmacies is very common in many developing countries and developed countries.”

The FOPE suggested the government to ensure that pharmacist should not be allowed to prescribe habit forming drugs or antibiotics as its resistance can cause havoc to patients. This move of the government can be implemented in phased manner. Once first phase is successful, second phase can be introduced, said Sikri.

Based on the deliberations of 52nd meeting of drugs consultative committee (DCC), the government formed a sub-committee comprising of five state drug controllers to recommend the list of OTC drugs to be sold in pharmacies.

The term of reference of the panel is to look into the drugs marketed in country vis-a-vis conditions for sale stipulated under various schedules like H, H1, G, X, K and suggest list of drugs which may be considered for marketing as OTC along with conditions to be followed.

The panel had written to all stakeholders seeking suggestions from them by January 15, 2018 in this regard.

FOPE in its recommendation to the panel stated that a separate category of drugs, which are not harmful and are safe enough to be dispensed without any prescription should be included in such a list. Advisory should also be sent to all universities and colleges where Pharmacy students study to specially focus on giving them training on prescription of medicines. Some of the drugs of Schedule H can be taken out and can be shifted to OTC category.

“So far as intention of government is clear, we as industry Association will always welcome such move. World is changing and we have to change along with the world in the overall benefit of consumer and patient as a whole. Such move will increase accessibility of drugs to consumers. Patients Safety should be the key Slogan of Pharmacist while prescribing the medicines,” he concluded.